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Means for creating a mass having structural integrity

机译:产生具有结构完整性的质量的方法

摘要

The present invention relates to a means for creating a mass having structural integrity, including a rapidly disintegratable tablet for administration with or without the use of water. The present invention has a wide variety of different uses and applications. One embodiment is a tablet intended for oral administration. The tablet comprises at least one active ingredient and a mixture of excipients. The excipients provide desired characteristics and physical properties and when the tablet is sintered or heated, excellent tablet binding characteristics are obtained. The tablet is intended primarily for oral administration and dissolves in the presence of water. Also disclosed is a process for the preparation of a rapidly disintegratable tablet for administration with or without the use of water. The process comprising dissolving at least one bulking agent and at least one structural agent in a suitable solvent, wherein the solvent provides high porosity upon drying; spray-drying or dispersing said dissolved mixture to obtain a bead or granulated product; dry blending at least one binding agent, and at least one active ingredient with the bead or granulated product to obtain a preformulation product or adding at least one active ingredient to the preformulation product dissolved or dispersed components before spray-drying or dispersing; compressing the preformulation product; and sintering or heating the preformulation product for a sufficient time and temperature to allow the binding agent to change status or melt and allow the binding agent to resolidify as the temperature is reduced to ambient temperature.
机译:本发明涉及一种用于产生具有结构完整性的团块的方法,包括一种可快速崩解的片剂,用于在有或没有水的情况下给药。本发明具有多种不同的用途和应用。一个实施方案是用于口服的片剂。片剂包含至少一种活性成分和赋形剂的混合物。赋形剂提供所需的特性和物理性质,并且当片剂被烧结或加热时,获得优异的片剂结合特性。该片剂主要用于口服,可在水存在下溶解。还公开了一种制备可快速崩解的片剂的方法,所述片剂在有或没有水的情况下给药。该方法包括将至少一种填充剂和至少一种结构剂溶解在合适的溶剂中,其中该溶剂在干燥时提供高孔隙率。喷雾干燥或分散所述溶解的混合物以获得珠或粒状产物;在喷雾干燥或分散之前,将至少一种粘合剂和至少一种活性成分与珠或粒状产物干混以获得预制剂,或将至少一种活性成分溶解或分散的组分加入预制剂中;压缩预制剂产品;烧结或加热预制剂产品足够的时间和温度,以使粘合剂改变状态或熔化,并在温度降至环境温度时使粘合剂重新固化。

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